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NDC 72603-0191-01 sapropterin dihydrochloride 100 mg/1 Details
sapropterin dihydrochloride 100 mg/1
sapropterin dihydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by NorthStar RxLLC. The primary component is SAPROPTERIN DIHYDROCHLORIDE.
MedlinePlus Drug Summary
Sapropterin is used along with a restricted diet to control blood phenylalanine levels in adults and children 1 month of age and older who have phenylketonuria (PKU; an inborn condition in which phenylalanine may build up in the blood and causes decreased intelligence and a decreased ability to focus, remember, and organize information). Sapropterin will only work for some people who have PKU, and the only way to tell if sapropterin will help a particular patient is to give the medication for a period of time and see whether his or her phenylalanine level decreases. Sapropterin is in a class of medications called cofactors. It works by helping the body to break down phenylalanine so it will not build up in the blood.
Related Packages: 72603-0191-01Last Updated: 05/19/2024
MedLinePlus Full Drug Details: Sapropterin
Product Information
| NDC | 72603-0191 |
|---|---|
| Product ID | 72603-191_0bad959e-817e-3055-e063-6294a90a7646 |
| Associated GPIs | |
| GCN Sequence Number | 063484 |
| GCN Sequence Number Description | sapropterin dihydrochloride TABLET SOL 100 MG ORAL |
| HIC3 | C7H |
| HIC3 Description | PKU TX AGENT-COFACTOR OF PHENYLALANINE HYDROXYLASE |
| GCN | 99211 |
| HICL Sequence Number | 035266 |
| HICL Sequence Number Description | SAPROPTERIN DIHYDROCHLORIDE |
| Brand/Generic | Generic |
| Proprietary Name | sapropterin dihydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sapropterin dihydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | SAPROPTERIN DIHYDROCHLORIDE |
| Labeler Name | NorthStar RxLLC |
| Pharmaceutical Class | Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215534 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 72603-0191-01 (72603019101)
| NDC Package Code | 72603-191-01 |
|---|---|
| Billing NDC | 72603019101 |
| Package | 120 TABLET in 1 BOTTLE (72603-191-01) |
| Marketing Start Date | 2023-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |